SURGIMESH®XB TINTRACK7Recalls & reported problems
Aspide Medical · A non woven, non knitted layer reinforcement material made from polypropylene and a silicone layer · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03700296903265), received between Dec 8, 2017 and Jan 19, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Microbial Contamination of Device” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Microbial Contamination of Device1
- Use of Device Problem1
Patient problems
- Patient Problem/Medical Problem1
- Seroma1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2018Microbial Contamination of Device; Microbial Contamination of Device
AN OPEN INCISIONAL HERNIA REPAIR WAS PERFORMED ON THE ANTERIOR SURFACE OF THE PATIENTS ABDOMINAL ON (B)(6) 2017. THE SURGIMESH WN WAS IMPLANTED ON THE PATIENTS MIDLINE LOCATED ON TOP OF FASCIA. THE SURGIMESH WN WAS A SINGLE USE STERILE DEVICE REMOVED FROM ITS STERILE PACKAGING IN THE OPERATING FIELD. A DRAIN WAS INSERTED AT THE END OF THE PROCEDURE AND REMOVED ON (B)(6) 2017. A SEROMA WAS NOTED TO HAVE FORMED ON (B)(6) 2017. THE SURGEON INVOLVED CHOSE TO NOT ADMINISTER ANTIBIOTICS AND THE SURGIMESH WN WAS REMOVED ON (B)(6) 2017.
Patient problems: Seroma
MAUDE report 7205099 ↗InjuryDec 8, 2017Use of Device Problem; Use of Device Problem
THE PATIENT HAD AN OPEN UMBILICAL HERNIA REPAIRED BY (B)(6) MD, (B)(6) HOSPITAL, USING SURGIMESH XB CK-7 ON (B)(6) 2017. SUBSEQUENTLY THE PATIENT DEVELOPED A BOWEL OBSTRUCTION. (B)(6), MD RE-OPERATED LAPAROSCOPICALLY AND FOUND ADHESIONS BETWEEN THE BOWEL, ABDOMINAL WALL, XB TINTRACK7 AND OTHER LOOPS OF BOWEL. THE XB TINTRACK7 WAS NOTED TO NOT BE FLAT AGAINST THE ABDOMINAL WALL. AFTER CAREFULLY LYSING ALL ADHESIONS WITHOUT DEVELOPING ANY ENTEROTOMIES, DR. (B)(6) REPAIRED THE HERNIA WITH ANOTHER UMBILICAL TYPE OF MESH. THE PATIENT RECOVERED FROM SURGICAL PROCEDURE.
Patient problems: Patient Problem/Medical Problem
MAUDE report 7099277 ↗
Other Mesh, Surgical, Polymeric devices
- PROCEED PVPMJohnson & Johnson International Inc. · Mesh, surgical, polymeric1,233 reports
- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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